Device product
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926
Z-0772-2024
Product summary
- Event
- Event 93632
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6,920 US; 57 OUS
- Official record key
device-enforcement:Z-0772-2024
Official wording
Reason: Affected lots may experience increased calibration failures or an increase in falsely elevated results.
Code information: UDI-DI 10758750001682 Lots 8931 8940 8955 8960 8970 8980 8990
Distribution pattern: Domestic distribution nationwide. OUS distribution to Bermuda, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Spain, Portugal, Russia, Denmark, Norway, Sweden, France, Belgium, and The Netherlands.
Derived failure modes
-
Unknown
Affected lots may experience increased calibration failures or an increase in falsely elevated results.